USP Dry Powder Injection Antibiotics Imipenem Cilastatin Sodium

USP Dry Powder Injection Antibiotics Imipenem Cilastatin Sodium

Product : Imipenem and Cilastatin Sodium for Injection

Specification : 250mg+250mg, 500mg+500mg

Standard : BP, USP

Packing : 1 vial/box, with or without solvent

Description :

Imipenem and Cilastatin for Injection, USP (I.V.) is a sterile formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I), with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is a potent broad spectrum antibacterial agent for intravenous administration.

Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product.

Indications and Usage :

Imipenem and cilastatin for injection (I.V.) is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

0.1 Lower respiratory tract infections. Staphylococcus aureus (penicillinase-producing strains), Acinetobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae1, Klebsiella species, Serratia marcescens

0.2 Urinary tract infections (complicated and uncomplicated). Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii1, Proteus vulgaris1, Providencia rettgeri1, Pseudomonas aeruginosa

0.3 Intra-abdominal infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Staphylococcus epidermidis, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii1, Proteus species, Pseudomonas aeruginosa, Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species1, Bacteroides species including B. fragilis, Fusobacterium species

0.4 Gynecologic infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Staphylococcus epidermidis, Streptococcus agalactiae (Group B streptococci), Enterobacter species1, Escherichia coli, Gardnerella vaginalis, Klebsiella species1, Proteus species, Bifidobacterium species1, Peptococcus species1, Peptostreptococcus species, Propionibacterium species1, Bacteroides species including B. fragilis1

0.5 Bacterial septicemia. Enterococcus faecalis, Staphylococcus aureus (penicillinase - producing strains), Enterobacter species, Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, Serratia species1, Bacteroides species including B. fragilis1

0.6 Bone and joint infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Enterobacter species, Pseudomonas aeruginosa

0.7 Skin and skin structure infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Acinetobacter species, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii, Proteus vulgaris, Providencia rettgeri1, Pseudomonas aeruginosa, Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B. fragilis, Fusobacterium species1

Endocarditis. Staphylococcus aureus (penicillinase-producing strains)

0.8 Polymicrobic infections. Imipenem and cilastatin for injection (I.V.) is indicated for polymicrobic infections including those in which S. pneumoniae (pneumonia, septicemia), S. pyogenes (skin and skin structure), or nonpenicillinase-producing S. aureus is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G.

Imipenem and cilastatin for injection (I.V.) is not indicated in patients with meningitis because safety and efficacy have not been established.